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EC number: 469-070-1 | CAS number: 17861-60-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The substance was tested according to OECD guidelines 423 (oral), 403 (inhalation) and 402 (dermal). No adverese effects were observed in the three studies.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 March to 25 March 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 30 September 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Specific density: 828 g/L at 20°C
Storage condition: ambient temperature - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: (WI) WU BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 166 -180 g
- Fasting period before study: Prior to dosing, fasted overnight until approx. 4h after dosing
- Housing: maximum of six animals per macrolon cage
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Administered dose volume: 2.42 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations 1h, 4h after dosing, subsequently daily; weighing on day 0, 3, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- Not conducted
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- no mortality
- Clinical signs:
- other: no clinical signs (with exception of tremors in 3 animals 1 hour after dosing only)
- Gross pathology:
- no findings
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for oral toxicity to female rats was determined to be > 2000 mg/kg bw. The substance is not classified according to CLP criteria.
- Executive summary:
The acute oral (gavage) toxicitity of heptamethylethyltrisiloxane was investigated in female Wistar derived rats at a dose level of 2000 mg/kg bw followed by a 14 day observation period. The test substance was dosed undiluted. There were no deaths at 2000 mg/kg bw, therefore no further testing was required. There were no treatment related clinical signs, and all animals gained bodyweight during the observation period. Examination at necropsy revealed no effects of the test substance.
The acute oral median lethal dose (LD50) of heptamethylethyltrisiloxane in rats was found to be greater than 2000 mg/kg bw therefore the substance is not classified according to CLP criteria.
Reference
Table 1: Acute oral toxicity of the test item in rats, individual and mean body weights, doses amounts applied and mortality
Animal no | Dose applied [mL] |
Body weights [g] recorded on day: | Mortality [dead/survived] |
|||
0 | 3 | 7 | 14 | |||
2000mg/kg bw (first group) | ||||||
41 | 0.43 | 180 | 195 | 197 | 207 | -- |
43 | 0.42 | 174 | 186 | 194 | 212 | -- |
45 | 0.41 | 169 | 186 | 189 | 201 | -- |
mean | 174 | 189 | 193 | 203 | 0/3 | |
2000mg/kg bw second group) | ||||||
59 | 0.4 | 166 | 183 | 187 | 198 | -- |
61 | 0.41 | 170 | 190 | 197 | 213 | -- |
63 | 0.43 | 180 | 196 | 205 | 210 | -- |
172 | 190 | 196 | 207 | 0/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-07-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes
- Limit test:
- yes
- Specific details on test material used for the study:
- Batch/lot number:Taf 002
Purity >95%
Density 828 g/L - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI) WU BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 - 6 weeks
- Mean weight at study initiation: male: 215 g female: 160 g
- Housing: individually during exposure, 5 per cage during 14 days observation (divided by sex)
- Diet (e.g. ad libitum): ad libitum, except during exposure
- Water (e.g. ad libitum): ad libitum, except during exposure
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21,6 +/- 0.2°C
- Humidity: 64 +/- 1%
- Air changes (per hr): 10
- Photoperiod (dark/light): 12 h/12 h - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: humidified air
- Remark on MMAD/GSD:
- N/A test substance tested as vapour
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose only inhalation chamber
- Exposure chamber volume: ca 50 L
- Method of holding animals in test chamber: Battelle plastic animal holders
- Source and rate of air: compressed dry air and 16.6 L/min
- Method of conditioning air: humidifier
- System of generating particulates/aerosols: N/A test substance tested as vapour
- Method of particle size determination: N/A test substance tested as vapour
- Treatment of exhaust air: filter
- Temperature, humidity, pressure in air chamber: 21.6 +/-0.1°C, 55 +/-1%, not reported except that positive pressure was maintained in chamber
TEST ATMOSPHERE
- Brief description of analytical method used: test atmosphere was sampled by passing metered amounts of test atmosphere through a cascade of a primary and secondary impinger filled with methanol. Samples were analysed after dilution with water. The concentration of test material in the impinger solution was determined by measuring the concentration of elemental Si using ICP-AES
- Samples taken from breathing zone: no
VEHICLE
- Composition of vehicle (if applicable): N/A
- Concentration of test material in vehicle (if applicable): N/A
- Justification of choice of vehicle: N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: N/A
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): N/A
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: N/A - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 10.0 +/- 0.4 g/m3 (highest attainable concentration)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 10 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Male: 10 mg/L; Number of animals: 5; Number of deaths: 0
Female: 10 mg/L; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Although observation of the rats was limited during exposure due to the stay in restraining tubes, a slightly decreased breathing rate was observed in all animals at all four (approximately hourly) observation
- Body weight:
- Although body weight gain in male animals was slightly lower in the first than in the second week, overall, body weight gain was as expected for animals of this strain and age.
- Gross pathology:
- At necropsy, macroscopic abnormalities consisted of petechiae on the lobes of the lungs in three male animals. In one male animal petechiae were seen on one lobe and in two male animals these petechiae were seen on all lobes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no mortalities in male and female rats following a 4-hour nose-only exposure to heptamethylethyltrisiloxane at the maximum attainable concentration of 10 g/m3. Therefore the LC50 of vapour of heptamethylethyltrisiloxane >10 g/m3 for both sexes
- Executive summary:
In an acute inhalation study, groups of Wistar derived rats (5/sex) were exposed by the inhalation route (nose-only) for a single 4-hour period to the maximium attainable concentration of 10 g/m3 heptamethylethyltrisiloxane vapour. Following exposure, animals were observed for 14 days. No mortalities occurred. Shortly after exposure cinical signs consisted of red/brown discolouration of the head in all female animals. No other treatment related clinical signs of toxicity were observed. Body weight gain was within limits of that expectd for animals of this age and strain. At necropsy, macroscopic changes were limited to petechiae seen on one or more lobes of the lungs in three male animals. Under the conditions of this study the rat acute inhalation 4 hour nose-only body LC50was >10 g/m3 in males and females.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 10 mg/L air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Oct 2016 - 17 Oct 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHAN (TM); WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200g, weight variation did not exceed +/- 20% of the mean weight for each sex
- Housing: individually during 24h exposure period, in groups of 5, by sex, for the remainder of the study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25°C
- Humidity: 30 - 70%
- Air changes (per hr): 15
- Photoperiod (dark / hrs light): 12h/12h
IN-LIFE DATES: From: 03 Oct 2016 To: 17 Oct 2016 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10%
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin and surrounding hair wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount applied: 2.44mL/kg bw - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Frequency of observations and weighing observation after dosing: 30min, 1, 2, 3 and 4 h and subsequently daily for 14 days, body weights recorded on days 0, 7 and 14
Evaluation of skin reactions: after removal of dressing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes - Statistics:
- Not performed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- no mortality observed
- Clinical signs:
- other: no signs of systemic toxicity observed
- Gross pathology:
- no abnormalities were noted at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw.
The test item does not meet the criteria for classification according to the Globally Harminized System of Classification and labelling of Chemicals. - Executive summary:
The acute dermal toxicity of heptamethylethyltrisiloxane was investigated in male and female RccHan:WIST rats at a dose level of 2000 mg/kg bw (24 hour exposure) followed by a 14 day observation period. There were no deaths at 2000 mg/kg bw. There were no treatment related clinical signs, nor effects on bodyweight gain with the exception of 2 females during the first week of observation. Histopathological examination revealed no effects of the test substance.
The acute dermal median lethal dose (LD50) of heptamethylethyltrisiloxane in rats was found to be greater than 2000 mg/kg bw
Reference
table1: results male
male animal nr |
observation time | ||
1-7d | 8-14d | ||
1-0 | erythema | 0 | 0 |
edema | 0 | 0 | |
1-1 | erythema | 0 | 0 |
edema | 0 | 0 | |
1-2 | erythema | 0 | 0 |
edema | 0 | 0 | |
1-3 | erythema | 0 | 0 |
edema | 0 | 0 | |
1-4 | erythema | 0 | 0 |
edema | 0 | 0 |
table 2: results female
female animal nr |
observation time | ||
1-7d | 8-14d | ||
2-0 | erythema | 0 | 0 |
edema | 0 | 0 | |
2-1 | erythema | 0 | 0 |
edema | 0 | 0 | |
2-2 | erythema | 0 | 0 |
edema | 0 | 0 | |
2-3 | erythema | 0 | 0 |
edema | 0 | 0 | |
2-4 | erythema | 0 | 0 |
edema | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
According to CLP (1272/2008/EC) classification criteria for acute toxicity, no classification is warranted.
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